Volume 2

Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology.

  • Great Britain. Parliament. House of Lords. Science and Technology Committee.
Date:
1993
Catalogue details

Licence: Open Government Licence

Credit: Regulation of the United Kingdom biotechnology industry and global competitiveness / Select Committee on Science and Technology. Source: Wellcome Collection.

    11/310 (page 3)
    11 March 1993 ] [Continued by the Royal Commission on Environmental Pollution. The first consultative proposals for implementing legislation were issued jointly by HSC and DoE in October 1991. They were extensively revised in the light of the comments that were received and reissued in August 1992, in a form that became the basis of the current regulations. As outlined in paragraph 5 above the regulations follow the structure of the directives themselves, with two sets, one for contained use and one for release, each dealing with the protection of human health and the environment (and drawing on the European Communities Act 1972 in order to go beyond the limits of HSWA and EPA in that respect). Main features of the GMO regulations 12. This submission concentrates on the 1992 Contained Use Regulations as it is these that are concerned most directly with human health protection, for which HSE is responsible. Organisms posing a more than an insignificant risk to human health would not be candidates for release (except in certain special circumstances of potentially high benefit, some vaccines and pharmaceuticals for example), and the focus of the deliberate release regulations is correspondingly on the protection of the environment. For these reasons HSE has taken the lead in the preparation and administration of the Contained Use Regulations, and DoE has led on release and marketing. Contained Use 13. The Contained Use Regulations follow closely the structure and terms of the Contained Use Directive, going beyond it only in two respects. They continue current UK legislative practice in applying not only to micro-organisms but also to the human health risks associated with large organisms such as plants and animals, while the directive is confined to micro-organisms. And they provide for certain information on GMO work to be made available by means of a public register. The directive does deal with information disclosure but is silent as to the means. 14. Acentral requirement of the Contained Use Regulations is that a risk assessment is carried out before work begins, so that containment measures can be currently selected. A system of notification and consent is set up, based on a classification scheme for both the organism and the activity in which it is used. There are provisions for the preparation of emergency plans, the notification of accidents, and for the disclosure and retention of information. Fuller details of the regulations are set out at Annex 1. The Contained Use Directive which underlies them is at Annex 2, and the regulations themselves, with accompanying guidance published by HSE, are at Annex 3. Deliberate release 15. The main features of the Environmental Protection Act and the 1992 Deliberate Release Regulations, in respect of the release and marketing of GMOs, are described in detail in separate evidence submitted to the Committee by DoE. They extend to a slightly wider range of GMOs than do the Contained Use Regulations, which exclude from their scope some low-hazard self-cloned organisms and the construction and use of somatic hybridoma cells. Provisions are included for the disclosure of information to the public but differ in some respects from those in the Contained Use Regulations, reflecting the greater significance of deliberate release to the public and the differences between contained use and release in the kind of protection that is needed for commercially sensitive information. Administration and enforcement 16. The two sets of regulations are administered jointly by HSE and DoE, together with the Ministry for Agriculture, Fisheries and Food as regards matters affecting its area of responsibility, and the Welsh and Scottish Offices as regards environmental matters in their territories. The regulations themselves require in particular that a contained use consent is not granted by HSE without the agreement of the Secretary of State for the Environment (or Scotland or Wales) insofar as it relates to environmental protection, and a reciprocal procedure operates for release and marketing consents granted by the Secretary of State insofar as they relate to the protection of human health. These arrangements and others for coordination and cooperation are the subject of a Memorandum of Understanding between the departments involved. 17. All this legislation is enforced by HSE. For the Contained Use Regulations the powers used are those conferred by the Health and Safety at Work Act. For the release legislation the Secretary of State’s enforcement functions under Part VI of the Environmental Protection Act have been delegated under an agency agreement to HSC, and thence to HSE. The agreement is to be reviewed in two or three years time to take account of the establishment of the planned Environment Agency. Inspection and enforcement are carried out by the team of specialist HSE inspectors, forming part of HSE’s Technology and Health Sciences Division, which was already enforcing the 1989 regulations. It has six members, all qualified at least to degree level in relevant disciplines. All undergo a one year HSE training programme before joining the team, and undertake in post a further structured programme of training and professional development in biotechnology.